Call for independent probe into prescribing of drug to pregnant women
MAYO Sinn Féin Senator Rose Conway-Walsh has called for an independent investigation on the historical prescribing of valproate to pregnant women.
She said it is now clear that hundreds of children have been born with disabilities as a direct result of the of the prescribing sodium valproate (epilim) which is a drug licensed in Ireland for the treatment of epilepsy and bi-polar disorder.
Senator Conway-Walsh said: “A ‘do nothing’ approach is not acceptable in this state.
"The crux of the matter is that parents were not informed of the risks or risk-reduction measures they needed to put in place, therefore they continued to be prescribed valporate during pregnancy.
"I am disturbed at the minister’s reluctance to hold an independent investigation in to the matter. I do welcome the recent report but there are still many questions to be answered:
“We need to know If and how existing cases of FACS could have been prevented. Whether or not appropriate and timely information was provided to healthcare professionals and patients in line with knowledge at the time.
“Whether or not appropriate decision making processes were in place concerning the treatment of women taking Valproate in line with knowledge at the time.
“Whether or not appropriate regulatory steps and communication mechanisms have been taken over time to ensure patient safety.
“How a system of redress can be established to meet the lifelong care needs of children and the impact of diagnosis on families (in order to avoid the need for legal solutions for already burdened families.
“The Department of Health must sign of funding for the established Valproate Project Group.
“This state is not the only jurisdiction to be affected by the Valporate scandal. In November last year the French government approved a €10 million fund to meet compensation claims as a starting point.
“In February this year the British Health secretary, Jeremy Hunt, announced a review of how Valproate concerns were handled in the past.
“Valproate-related disabilities are complex, wide-ranging and individual. Obtaining a diagnosis in Ireland is difficulty and lengthy. Treatment often involves attending a multitude of unconnected and uncoordinated speciality services. Often, families have more than one child affected and in many cases, full-time caring is required.
“It is therefore critical that appropriate supports are urgently put in place. I know families who desperately need therapies and treatment but they cannot afford them. They sit and watch while their children regress. This is an intolerable situation for them to be left in and must stop.
"These children need never have had to experience these disabilities. Their families need never have had to become life long carers. Their lives could have been totally different.”